Revisions in Validation Rules v 2.0 [200908241430]
Additions of text = underline
Deletions of text = strikethrough
New requirement / renumbering = bold
Header of file indicates this is still v2.0; FDA webpage indicates this is v2.1
Labeler information
1.4.2.2: There are two ids (except for an initial labeler code request, which should be submitted with only one id.)
1.4.2.6: One id has the root 2.16.840.1.113883.6.69 and an extension (except for an initial labeler code request, which should be submitted without this id.)
Product
2.1.2.14 Name contains no special symbols... and no "USP" ("USP" may be in the suffix).
2.1.2.21 If the NDC Product Code was previously submitted, with a marketing status date the same or earlier than the current date, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same as in the most recent submission for this NDC code.
Active Ingredient
2.1.4.2 If the product has no parts, then there are one or more active ingredients.
Active moiety
2.1.5.5 Active moiety does not include any of the names in the Active moiety validation (counter ion) list except if the word appears by itself optionally followed by "cation" or "anion" or "ion".
Packaging
2.1.8.23 If the NDC Product Code has been previously submitted, with a marketing status date the same or earlier than the current date, then the package form code and quantity value and unit are the same as in the most recent submission for this NDC code.
Parts
2.1.9.7 Name contains no special symbols... and no "USP" ("USP" may be in the suffix).
New Validation Rule
2.1.9.13 If the NDC Product Code of the part was previously submitted, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same as in the most recent submission for this NDC code
Renumbering of previous 2.1.9.13 to 2.1.9.14
Marketing Category
2.1.10.6: If the code is C73585, then the id extension has the prefix "BLA" followed by 6 digits.
2.1.10.8: If the code is C73594 or C73605 then the id extension has the prefix "NDA" followed by 6 digits
New Validation Rule
2.1.10.17 If the code is C73626, C73603, C73604, C76314, C76313 or C73627, then the document has at least one section with the code 51945-4.
Renumbering of previous 2.1.10.17 to 2.1.10.18.
Renumbering of previous 2.1.10.18 to 2.1.10.19.
Renumbering of previous 2.1.10.19 to 2.1.10.20.
Renumbering of previous 2.1.10.20 to 2.1.10.21.
Marketing Date
New Validation Rule
2.1.11.7 If there is a high value, then it is not less than the low value.
Revisions in Validation Rules v 2.0 [200908241430]
Additions of text = underline
Deletions of text = strikethrough
New requirement / renumbering = bold
Header of file indicates this is still v2.0; FDA webpage indicates this is v2.1
Labeler information
1.4.2.2: There are two ids (except for an initial labeler code request, which should be submitted with only one id.)1.4.2.6: One id has the root 2.16.840.1.113883.6.69 and an extension (except for an initial labeler code request, which should be submitted without this id.)
Product
2.1.2.14 Name contains no special symbols... and no "USP" ("USP" may be in the suffix).
2.1.2.21 If the NDC Product Code was previously submitted, with a marketing status date the same or earlier than the current date, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same as in the most recent submission for this NDC code.
Active Ingredient
2.1.4.2 If the product has no parts, then there are one or more active ingredients.
Active moiety
2.1.5.5 Active moiety does not include any of the names in the Active moiety validation (counter ion) list except if the word appears by itself optionally followed by "cation" or "anion" or "ion".
Packaging
2.1.8.23 If the NDC Product Code has been previously submitted, with a marketing status date the same or earlier than the current date, then the package form code and quantity value and unit are the same as in the most recent submission for this NDC code.
Parts
2.1.9.7 Name contains no special symbols... and no "USP" ("USP" may be in the suffix).
New Validation Rule
2.1.9.13 If the NDC Product Code of the part was previously submitted, then the product and generic name, active ingredient UNII, dosage forms, active ingredient strength, product characteristics of size, shape, color and imprint code are the same as in the most recent submission for this NDC code
Renumbering of previous 2.1.9.13 to 2.1.9.14
Marketing Category
2.1.10.6: If the code is C73585, then the id extension has the prefix "BLA" followed by 6 digits.
2.1.10.8: If the code is C73594 or C73605 then the id extension has the prefix "NDA" followed by 6 digits
New Validation Rule
2.1.10.17 If the code is C73626, C73603, C73604, C76314, C76313 or C73627, then the document has at least one section with the code 51945-4.
Renumbering of previous 2.1.10.17 to 2.1.10.18.
Renumbering of previous 2.1.10.18 to 2.1.10.19.
Renumbering of previous 2.1.10.19 to 2.1.10.20.
Renumbering of previous 2.1.10.20 to 2.1.10.21.
Marketing Date
New Validation Rule
2.1.11.7 If there is a high value, then it is not less than the low value.